Cost-effectiveness of combination daclatasvir-sofosbuvir for treatment of genotype 3 chronic hepatitis C infection in the United States

Abstract

Background: A phase III trial evaluated the efficacy and safety of Daklinza (daclatasvir or DCV) in combination with sofosbuvir (SOF) for treatment of genotype (GT) 3 hepatitis C virus (HCV) patients.

Aim: This study evaluated the cost-effectiveness of DCV + SOF vs SOF in combination with ribavirin (RBV) over a 20-year time horizon from the perspective of a United States (US) payer.

Methods: A published Markov model was adapted to reflect US demographic characteristics, treatment patterns, costs of drug acquisition, monitoring, disease and adverse event management, and mortality risks. Clinical inputs came from the ALLY-3 and VALENCE trials. The primary outcome was the incremental cost-utility ratio. Life-years, incidence of complications, number of patients achieving sustained virological response (SVR), and the total cost per SVR were secondary outcomes. Costs (2014 USD) and quality-adjusted life years (QALYs) were discounted at 3% per year. Deterministic, probabilistic, and scenario sensitivity analyses were conducted.

Results: DCV + SOF was associated with lower costs and better effectiveness than SOF + RBV in the base case and in almost all scenarios (i.e. treatment-experienced, non-cirrhotic, time horizons of 5, 10, and 80 years). DCV + SOF was less costly, but also slightly less effective than SOF + RBV in the cirrhotic and treatment-naïve population scenarios. Results were sensitive to variations in the probability of achieving SVR for both treatment arms. DCV + SOF costs less than $50,000 per QALY gained in 79% of all probabilistic iterations compared with SOF + RBV.

Conclusion: DCV + SOF is a dominant option compared with SOF + RBV in the US for the overall GT 3 HCV patient population.

Keywords:

• Daclatasvir
• Sofosbuvir
• Hepatitis C
• Cost-effectiveness
• Cost-benefit analysis

Transparency

Declaration of funding

Funding for this study was provided by Bristol-Myers Squibb. The funder provided support in the form of consulting fees for some authors [CST, DM, and MLG] and salaries for other authors [BS, SH, YY, and BG].

Declaration of financial/other interests

CST and MLG are employees of Evidera, Inc., an independent research organization that received consulting fees from Bristol-Myers Squibb for the development of this paper. BS, SH, and YY are employees of Bristol-Myers Squibb, the manufacturer of daclatasvir. At the time of this research project, DM and BG were employees of Evidera and Bristol-Myers Squibb, respectively, but are currently employed elsewhere. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentation

Presented at the AASLD conference, San Francisco, CA, November 13–17, 2015.

Acknowledgments

The authors would like to acknowledge Michael Byrnes from Evidera for his help in writing this manuscript, as well as Lisa Rosenblatt from Bristol-Myers Squibb for her help in reviewing this paper.